Good manufacturing practice" or "GMP" is part of a quality system covering the

manufacture and testing of active pharmaceutical ingredients, diagnostics, foods,

pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects
of production and testing that can impact the quality of a product. Many countries have
legislated that pharmaceutical and medical device companies must follow GMP procedures,
and have created their own GMP guidelines that correspond with their legislation.

Although there are a number of them, all guidelines follow a few basic principles.

• Manufacturing processes are clearly defined and controlled. All critical processes are
validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated.
Changes that have an impact on the quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous language. (Good
Documentation Practices)
• Operators are trained to carry out and document procedures.
• Records are made, manually or by instruments, during manufacture that demonstrate
that all the steps required by the defined procedures and instructions were in fact
taken and that the quantity and quality of the drug was as expected. Deviations are
investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a
batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the drugs minimizes any risk to their quality.
• A system is available for recalling any batch of drug from sale or supply.
• Complaints about marketed drugs are examined, the causes of quality defects are
investigated, and appropriate measures are taken with respect to the defective drugs
and to prevent recurrence.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a
series of general principles that must be observed during manufacturing. When a company is
setting up its quality program and manufacturing process, there may be many ways it can
fulfill GMP requirements. It is the company's responsibility to determine the most effective
and efficient quality process.

Hazard Analysis Critical Control Point (HACCP) is a systematic preventive approach to

food safety and pharmaceutical safety that addresses physical, chemical, and biological
hazards as a means of prevention rather than finished product inspection. HACCP is used in
the food industry to identify potential food safety hazards, so that key actions, known as
Critical Control Points (CCPs) can be taken to reduce or eliminate the risk of the hazards
being realized. The system is used at all stages of food production and preparation processes
including packaging, distribution, etc. The Food and Drug Administration (FDA) and the
United States Department of Agriculture (USDA) say that their mandatory HACCP programs
for juice and meat are an effective approach to food safety and protecting public health. Meat
HACCP systems are regulated by the USDA, while seafood and juice are regulated by the
FDA. The use of HACCP is currently voluntary in other food industries.[1]
A forerunner to HACCP was developed in the form of production process monitoring during
World War II because traditional "end of the pipe" testing wasn't an efficient way to ferret out
artillery shells that would not explode. HACCP itself was conceived in the 1960s when the
US National Aeronautics and Space Administration (NASA) asked Pillsbury to design and
manufacture the first foods for space flights. Since then, HACCP has been recognized
internationally as a logical tool for adapting traditional inspection methods to a modern,
science-based, food safety system. Based on risk-assessment, HACCP plans allow both
industry and government to allocate their resources efficiently in establishing and auditing
safe food production practices. In 1994, the organization of International HACCP Alliance
was established initially for the US meat and poultry industries to assist them with
implementing HACCP and now its membership has been spread over other
professional/industrial areas.[2]

Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics
and pharmaceuticals. This method, which in effect seeks to plan out unsafe practices, differs
from traditional "produce and test" quality control methods which are less successful and
inappropriate for highly perishable foods. In the US, HACCP compliance is regulated by 21
CFR part 120 and 123. Similarly, FAO/WHO published a guideline for all governments to
handle the issue in small and less developed food businesses.[3]

The HACCP seven principles

Principle 1: Conduct a hazard analysis. Plans determine the food safety hazards and
identify the preventive measures the plan can apply to control these hazards. A food safety
hazard is any biological, chemical, or physical property that may cause a food to be unsafe
for human consumption.

Principle 2: Identify critical control points. A Critical Control Point (CCP) is a point, step,
or procedure in a food manufacturing process at which control can be applied and, as a result,
a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.

Principle 3: Establish critical limits for each critical control point. A critical limit is the
maximum or minimum value to which a physical, biological, or chemical hazard must be
controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

Principle 4: Establish critical control point monitoring requirements. Monitoring

activities are necessary to ensure that the process is under control at each critical control
point. In the United States, the FSIS is requiring that each monitoring procedure and its
frequency be listed in the HACCP plan.

Principle 5: Establish corrective actions. These are actions to be taken when monitoring
indicates a deviation from an established critical limit. The final rule requires a plant's
HACCP plan to identify the corrective actions to be taken if a critical limit is not met.
Corrective actions are intended to ensure that no product injurious to health or otherwise
adulterated as a result of the deviation enters commerce.

Principle 6: Establish record keeping procedures. The HACCP regulation requires that all
plants maintain certain documents, including its hazard analysis and written HACCP plan,
and records documenting the monitoring of critical control points, critical limits, verification
activities, and the handling of processing deviations.

Principle 7: Establish procedures for ensuring the HACCP system is working as

intended. Validation ensures that the plants do what they were designed to do; that is, they
are successful in ensuring the production of safe product. Plants will be required to validate
their own HACCP plans. FSIS will not approve HACCP plans in advance, but will review
them for conformance with the final rule.

Verification ensures the HACCP plan is adequate, that is, working as intended. Verification
procedures may include such activities as review of HACCP plans, CCP records, critical
limits and microbial sampling and analysis. FSIS is requiring that the HACCP plan include
verification tasks to be performed by plant personnel. Verification tasks would also be
performed by FSIS inspectors. Both FSIS and industry will undertake microbial testing as
one of several verification activities. Verification also includes 'validation' - the process of
finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical
limitations).

[edit] Standards
The seven HACCP principles are included in the international system ISO 22000. This
standard is a complete food safety management system incorporating the elements of
prerequisite programmes for food safety, HACCP and quality management system which
together form an organization’s Total Quality Management.

HACCP application (USA)

• Fish and fishery products [13]
• Fresh-cut produces [14]
• Juice and nectary products [15]
• Food outlets [16]
• Meat and poultry products [17]
• School food and services [18]

[edit] HACCP implementation

It involves monitoring, verifying and validating of the daily work that is compliant with
regulatory requirements in all stages all the time. The differences among those three types of
work are given by Saskatchewan Agriculture and Food [19]